LexaGene Provides Update on Commercializing its Automated Pathogen Detection System
BEVERLY, Mass. USA – June 1, 2020 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”) a biotechnology company that develops genetic analyzers for rapid pathogen detection is pleased to provide the following update on the Company’s development plans of its flagship pathogen detection platform for the human clinical, veterinary diagnostics, and food safety sectors.
As previously announced, LexaGene has recently placed a pre-commercial unit of its LX Analyzer in a major US hospital laboratory for the testing of COVID-19 and has submitted its plan to the FDA for Emergency Use Authorization (EUA). The Company also recently gave an interview to expand on this news.
Dr. Jack Regan, CEO and Founder of LexaGene, states, “The analyzer’s multiplex testing capability is an important part of future testing needs, especially if the anticipated second wave of COVID-19 testing in the fall occurs with the added burden of a new flu season. The LX Analyzer is capable of testing for COVID-19, as well as flu and other common respiratory pathogens such as adenovirus and RSV at the point-of-need in clinics, hospitals, or elsewhere in the field. Hospitals have told us what they need, and we are working with partners on the research of this deadly virus with the hope of being the testing provider they choose. We are pleased so far with the results of our current placement.”
To support ramping up of final improvements to the pre-commercial system and manufacturing process, LexaGene has recently hired two additional members to the product development team in the areas of software and systems engineering. The Company also plans to hire sales staff in the summer in advance of the commercial launch in the fall.
LexaGene is in the final stages of selecting a contract manufacturer to assist beyond the Company’s in-house manufacturing capabilities in scaling up production of its analyzers in the fall to help meet the demand of testing needs in various markets.
As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.
On Behalf of the Board of Directors
Signed “Dr. Jack Regan”
Dr. Jack Regan, Chairman of the Board of Directors & Chief Executive Officer
About LexaGene Holdings Inc.
LexaGene is a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go’. The LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can return results in about 1 hour. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.
The TSX Venture Exchange Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues — that could cause actual results to differ materially from the Company’s expectations as disclosed in the Company’s documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.